Quality Systems Manager
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Pendleton • South Carolina • United States
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About the role
- Managing, improving, and maintaining the Arthrex manufacturing site Quality System in accordance with the Arthrex Global QMS to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements.
- Ensuring that the Arthrex Global QMS is supported, maintained, and improved at the site manufacturing level.
- Providing training to relevant personnel as required.
- Leading, managing, and developing a staff of Quality Systems dedicated Quality Engineers and Technicians.
- Driving the use of and educating others on mechanisms to solve problems that impede compliance and progress.
- Proactively evaluating and managing site process audits and correcting when applicable.
- Monitoring, identifying, and correcting systemic nonconformance trends on a continuous basis.
- Leading efforts to identify, implement, and harmonize site and industry best practices.
- Developing/defining a process for continuous improvement of the site quality system.
- Mentoring and coaching others in enhancing the Quality System.
Requirements
- Bachelor’s degree required, preferably in an Engineering discipline
- 5 years experience in a medical device company in a quality management and/or quality engineering role required
- Strong working knowledge of FDA Quality System Regulation, ISO 13485 and applicable international regulations
- Meets deadlines consistently
- Strong problem-solving skills, initiative and motivation for improvements
- Good project management skills
- Strict attention to detail
- Excellent communication skills are essential.
- Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents), PowerPoint, SAP or similar business software
Benefits
- Medical, Dental and Vision Insurance
- Company-Provided Life Insurance
- Voluntary Life Insurance
- Flexible Spending Account (FSA)
- Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
- Matching 401(k) Retirement Plan
- Annual Bonus
- Wellness Incentive Program
- Free Onsite Medical Clinics
- Free Onsite Lunch
- Tuition Reimbursement Program
- Trip of a Lifetime
- Paid Parental Leave
- Paid Time Off
- Volunteer PTO
- Employee Assistance Provider (EAP)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality managementquality engineeringcontinuous improvementprocess auditsproblem-solvingproject managementattention to detailtrainingmentoringcompliance
Soft Skills
leadershipcommunicationinitiativemotivationteam developmentcoachingorganizational skillsanalytical skillsinterpersonal skillsadaptability